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RecruitingNCT06454006Updated Apr 23, 2026

Effects of PBMT-sMF in Mechanically Ventilated Patients

An interventional study of Placebo PBMT-sMF and Active PBMT-sMF in Respiratory Failure, sponsored by University of Nove de Julho. Recruiting at 1 site in Brazil. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate the effectiveness of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) in adult patients who require mechanical ventilation. The main questions it aims to answer are:

(i) Does PBMT-sMF lower the length of stay in the intensive care unit (ICU) for mechanically ventilated patients? (ii) Does PBMT-sMF increase the diaphragm thickness in mechanically ventilated patients in the ICU?

Researches will compare active PBMT-sMF plus standard of care to a placebo PBMT-sMF plus standard of care to see if active PBMT-sMF works to prevent or retard disuse atrophy of the diaphragm during mechanical ventilation.

Read the detailed description

To achieve the proposed objectives it will be performed a multi-center, randomized, triple-blinded (patients, therapists, outcome assessors), placebo-controlled trial, in patients who required mechanical ventilation.

One hundred and twelve patients will be randomly allocated to two treatment groups:

  1. Active treatment: Patients will receive treatment with the active PBMT-sMF combined with standard of care therapy for a mechanically ventilated patient in the ICU.
  2. Placebo treatment: Patients will receive treatment with the placebo PBMT-sMF combined with standard of care therapy for a mechanically ventilated patient in the ICU.

The randomization will occur immediately following patients qualification and prior to any additional study activities occurring.

The treatment administration protocol (28-day administration protocol) will comprise: 7-minute treatment administration per day on each consecutive day for four consecutive weeks, for a maximum of 28 consecutive treatments over 28 consecutive days, or until the day of the patient's successful weaning from mechanical ventilation, or until the day of the patient's death, whichever occurs first.

The data will be collected by a blinded assessor.

Due to the nature of the condition being evaluated in this study, the study assessment timeline is patient dependent and will therefore be unique to each patient.

The study will comprise:

  1. pre-treatment evaluation phase (before starting treatment);
  2. treatment administration phase (two assessments: after completion of 14 and 28 days of treatment);
  3. post-treatment evaluation phase (any patient who is not discharged from the hospital or who does not die during the treatment administration and evaluation phase will proceed to the post-treatment administration phase. The post-treatment phase will start on the day immediately following the patient's last day in the treatment administration evaluation phase. The post-treatment phase will end on the day that the patient is discharged from the hospital, or the day that the patient dies prior to discharge from the hospital, whichever occurs firs. Therefore, the duration of the post-treatment administration phase will vary by individual patient. During the post-treatment evaluation period, the following assessments will be recorded once every two weeks, as applicable, with the final post-treatment evaluation visit determined on an individual patient basis, up to 2 years).

P.S.:

  • For patients whose successful weaning from mechanical ventilation occurs prior to completion of the 28-day administration protocol, the endpoint assessment visit will occur on or after the day of successful weaning.
  • For patients who die before completion of the 28-day administration protocol, the endpoint assessment visit will include outcome measures recorded as close to the date of the patient's death as possible.

The investigators will analyze: 1) Length of stay in the ICU; 2) Diaphragm thickness; 3) Length of stay in the hospital following ICU discharge; 4) Length of time until weaning from mechanical ventilation; 5) Mechanical ventilation parameters: (i) Positive end-expiratory pressure levels (PEEP) and (ii) Fraction of inspired oxygen (FiO2); 6) Arterial blood gas analysis: (i) Arterial partial pressure of oxygen (PO2) and (ii)PO2/FiO2 ratio; 7) Vital signs: blood pressure, heart rate, SpO2, blood glucose, etc.; 8) Blood draw analysis: C-reactive protein (CRP); Tumor necrosis factor-alpha (TNF-α); Vitamin D; erythrocytes; hemoglobin; hematocrit; leucocytes; segmented neutrals; eosinophiles; basophiles; lymphocytes; monocytes; platelet count;8) Survival rate; 9) Local skin reactions; 10) Adverse events and serious adverse events.

The statistical analysis will follow the intention-to-treat principles.

02

Conditions studied

  • Respiratory Failure

Keywords

  • Mechanical ventilation
  • Photobiomodulation therapy
  • LLLT
  • Static magnetic field
  • Diaphragm
  • Intensive care unit
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 112 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

University of Nove de Julho is the lead sponsor of 239 studies on the registry; 51 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Legally authorized representative signed informed consent;
  • Male or female aged 21 years or older;
  • On mechanical ventilation through orotracheal intubation for no more than 72 hours prior to study enrollment or pending mechanical ventilation through orotracheal intubation;
  • Predicted to remain on mechanical ventilation for at least 48 hours (≥48 hours) from the time of study enrollment

Exclusion criteria

Exclusion Criteria:

  • Mechanical ventilation initiated longer than 72 hours prior to anticipated enrollment;
  • Body Mass Index (BMI) > 40 kg/m²;
  • Fever of 100.4°C or higher;
  • Situated in the prone position for 24 hours or longer during mechanical ventilation;
  • Prognosis of mortality within 72 hours, per the patient's physician;
  • Hypersensitivity to light;
  • Use of non-invasive ventilation, Continuous Positive Airway Pressure (CPAP) and/or Bilevel Positive Airway Pressure (BiPAP) device for ≥ 50% of the time over the preceding 6 months;
  • Tracheostomy;
  • Any one or more of the following present on both sides of the neck (bilaterally) at the intended treatment site(s): internal jugular (IJ) venous cannulation; incisions, significant bruising; burn(s); notable skin irritation/rash, or other skin condition that may place the subject at risk from harm from the device treatment;
  • Fracture, external or internal hemorrhage, or at risk of hemorrhage following acute trauma or fracture, or known or potential acute occult bleeding (e.g., gastric ulcer, intestine) in the intended treatment areas;
  • Metallic device implants or body penetrating metallic devices in the upper body/neck area whose location may interfere with the study device treatment administration. E.g., extracorporeal membrane oxygenation (ECMO) cannula;
  • Non-removable electrical/electronic device in the upper body/neck area that may interfere with the study device treatment administration, e.g., -implanted pacemaker or cardiac defibrillator;
  • Cardiogenic or septic shock with ongoing severe hemodynamic instability (according to the American College of Chest Physicians definition (that cannot be stabilized within the 48 hours enrollment period);
  • Conditions that may limit ultrasonographic assessment of diaphragmatic thickness, e.g., occluding chest drain, pleural effusion, pulmonary consolidation of the lower lobe(s);
  • Current cancer of any type;
  • Pregnancy;
  • Any comorbidity, co-existing condition or illness, or other factor that in the opinion of the study investigator may render the subject unsuitable for participation in the study;
  • Admission to the ICU within the last 12 months due to respiratory distress/failure;
  • Two or more admissions to the ICU within the prior 12 months for any reason;
  • Current participation in another clinical study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
112 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Placebo treatment will be delivered using Multi Radiance® Medical PhotOxyl photoceutical medical device emitting a light source that is sufficient to be indistinguishable from the active comparator but does not deliver any therapeutic energy, combined with standard of care therapy for a mechanically ventilated patient in the ICU. The treatment administration protocol comprises one 7-minute treatment administration per day on each consecutive day for four consecutive weeks, for a maximum of 28 consecutive treatments over 28 consecutive days, or until the day of the subject's successful weaning from mechanical ventilation, or until the day of the subject's death, whichever occurs first.

    Device: Placebo PBMT-sMF

  • Active comparator
    Active

    Active treatment will be delivered using Multi Radiance® Medical PhotOxyl photoceutical medical device in active mode, combined with standard of care therapy for a mechanically ventilated patient in the ICU. The treatment administration protocol comprises one 7-minute treatment administration per day on each consecutive day for four consecutive weeks, for a maximum of 28 consecutive treatments over 28 consecutive days, or until the day of the subject's successful weaning from mechanical ventilation, or until the day of the subject's death, whichever occurs first.

    Device: Active PBMT-sMF

Interventions

  • DevicePlacebo PBMT-sMF

    Placebo, without therapeutic dose.

  • DeviceActive PBMT-sMF

    Active with a dose of 31.50 J per site.

06

What researchers measure

Primary outcomes

  1. Length of stay in the intensive care unit (ICU)

    Number of days hospitalized in the ICU until discharge from ICU.

    Time frame: From date of ICU admission until the date of discharge of the ICU.

Secondary outcomes

  1. Length of stay in the hospital

    Number of days from the patient's admission to the hospital, following discharge from the ICU, to the patient's discharge from the hospital or death from any cause, whichever came first.

    Time frame: Assessments once every two weeks after discharge from ICU until the date of discharge of hospital or date of death from any cause, whichever came first, up to 2 years.

  2. Length of time until weaning from mechanical ventilation (MV)

    The number of days from patient initiation on MV until successful weaning.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks until the date of successful weaning from MV or date of death, whichever came first, up to 2 years.

  3. Levels of positive end-expiratory pressure levels (PEEP)

    The levels of PEEP will be measured using a mechanical ventilator.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks until the date of successful weaning from MV or date of death, whichever came first, up to 2 years.

  4. Levels of fraction of inspired oxygen (FiO2)

    The levels of PEEP will be measured using a mechanical ventilator.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks until the date of successful weaning from MV or date of death, whichever came first, up to 2 years.

  5. Arterial partial pressure of oxygen (PO2)

    PO2 will be measured by arterial blood gas analysis.

    Time frame: After completion of 14 days of treatment; after completion of 28 days of treatment, and assessments once every two weeks until the date of successful weaning from mechanical ventilation or date of death, whichever came first, up to 2 years.

  6. Arterial partial pressure of oxygen (PO2)/Fraction of inspired oxygen (FiO2) ratio

    PO2 will be measured by arterial blood gas analysis.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks until the date of successful weaning from MV or date of death, whichever came first, up to 2 years.

  7. C-reactive protein (CRP)

    CRP will be measured by blood test.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

  8. Erythrocytes

    Erythrocytes will be measured by blood test.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

  9. Hemoglobin

    Hemoglobin will be measured by blood test.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

  10. Hematocrit

    Hematocrit will be measured by blood test.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

  11. Leucocytes

    Leucocytes will be measured by blood test.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

  12. Segmented neutrals

    Segmented neutrals will be measured by blood test.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

  13. Eeosinophiles

    Eosinophiles will be measured by blood test.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

  14. Basophiles

    Basophiles will be measured by blood test.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

  15. Lymphocytes

    Lymphocytes will be measured by blood test.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

  16. Monocytes

    Monocytes will be measured by blood test.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

  17. Platelet count

    Platelet count will be measured by blood test.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

  18. Survival rate

    Rate of how many people survived and were discharged and how many died.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

  19. Local skin reactions

    Local skin reaction will be measured by four-point post-treatment assessment severity scale

    Time frame: After each treatment administration up to 28 days.

  20. Adverse events

    All adverse events that occur after randomization, including local and systemic reactions, not meeting the criteria for serious adverse events will be captured on the appropriate adverse event case report form.

    Time frame: Adverse events will be collected throughout study duration up to 2 years.

  21. End-expiratory diaphragm thickness

    Diaphragm thickness will be measured by ultrasound.

    Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.

07

Study locations

1 of 1 sites recruiting
  • Santa Casa de Misericórdia de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90035-074, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The IPD will be available on reasonable request.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06454006
Lead sponsor
University of Nove de Julho
Collaborators
Multi Radiance Medical
Responsible party
Ernesto Cesar Pinto Leal Junior (Full professor, University of Nove de Julho) — Principal investigator
First posted
Jun 12, 2024
Start date
Jul 31, 2024
Primary completion
Dec 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Apr 23, 2026

Study contacts

Ernesto Leal Junior, PhD
Contact
ernesto.leal.junior@gmail.com
+551133859134
Ernesto Leal Junior, PhD
principal investigator · University of Nove de Julho

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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